ASSOCIATE DIRECTOR, CMC REGULATORY AFFAIRSSUMMARY:This individual's primary responsibility will be to establish and execute global CMC regulatory strategies for commercial compounds in Ionis' product pipeline. This is a team and individual contributor role, reporting to the Director, CMC Regulatory Affairs. This individual will collaborate and coordinate cross-functionally at Ionis, and with partner companies and vendors, to complete accurate and compliant regulatory documentation and ensure all regulatory requirements are met according to established timelines. The successful candidate will be able to: (1) understand and fulfill complex CMC requirements for global submissions, (2) work independently to manage projects and deliver output in a timely manner with limited supervision, (3) provide CMC regulatory leadership within Regulatory Affairs and on cross-functional teams, (4) serve as a liaison between regulatory authorities and the company regarding CMC issues to ensure timely approvals, (5) manage progress and completion of responsibilities to ensure delivery of CMC regulatory submissions in accordance with health authority deadlines, established departmental goals and objectives, and project plans and milestones, and (6) maintain current knowledge and expertise of relevant FDA, EMA, MHRA, JP, CN, and ICH guidelines and regulations.
WORK LOCATION: onsite/hybrid - Carlsbad, CA preferred; open to remote
RESPONSIBILITIES: - Develop and execute global CMC regulatory strategies in collaboration with CMC RA colleagues and CMC subject matter experts in an environment committed to the efficient and aggressive development and commercialization of new drugs for patients
- Lead the preparation of complex CMC regulatory submissions for new drug applications in US, Canada, EU, UK, MENA, LATAM, and APAC regions by navigating and fulfilling regional regulatory requirements, customizing CTD sections, and collecting necessary ancillary documents
- Lead CMC regulatory aspects of partnered programs to ensure overall CMC strategy is achieved and to ensure delivery of required regulatory support and submissions
- Prepare, communicate, and drive timelines to ensure delivery of CMC regulatory submissions in accordance with health authority deadlines, established departmental goals and objectives, and project plans and milestones
- Facilitate timely regulatory approvals of new drug applications by ensuring the quality, accuracy, and completeness of submissions
- Understand and fulfill CMC post-approval regulatory activities for commercial products by assessing regulatory impact of manufacturing change controls, preparing post-approval changes/ variations, and performing lifecycle maintenance across global markets
- Participate in cross-functional teams to lead the timely preparation of high-quality regulatory submissions (including initial NDAs, post-approval changes/variations, query responses, and briefing documents)
- Support scientific advice / meetings with regulatory agencies to resolve CMC issues and ensure efficient drug development and drug approval
- Maintain knowledge of current and emerging regulatory legislation/guidance impacting CMC requirements
COMPETENCIES IDENTIFIED FOR SUCCESS - Proven functional expertise with preparation and execution of CMC regulatory strategies and submissions for global markets
- Strong and effective communication (verbal and written), interpersonal, and teamwork skills
- Action-oriented, with ability to efficiently manage multiple priorities with aggressive timelines at a high level of productivity and proficiency
- Detail-oriented, with proficient regulatory writing skills
- Ability to work effectively and collaboratively towards a shared goal
- Ability to work independently to manage projects and deliver output in a timely manner with limited supervision
REQUIREMENTS:- Bachelor's Degree in a scientific discipline (e.g., chemistry, biological sciences, engineering) required; advanced degree preferred
- Minimum of 12 years of regulatory experience in the pharmaceutical industry
- Successful experience interacting with regulatory agencies
- Demonstrated ability to prepare and deliver complex CMC regulatory submissions for new drug applications and post-approval changes/variations in US, Canada, EU, UK, MENA, LATAM, and APAC regions
- Strong knowledge of eCTD elements and structure
- Strong knowledge of commercial lifecycle management requirements
- Proficiency in FDA, EU, ICH, USP, EP, JP, and other global requirements and guidelines related to regulatory submissions and cGMP operations
- Demonstrated ability to leverage artificial intelligence tools as an aid to support and enhance the execution of complex tasks, prepare presentations, and improve efficiency
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004158
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis BenefitsFull Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits
The pay scale for this position is $181,162 to $224,717
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
